What is the authoritative US document that delineates concrete standards for vaccine approval? Presumably said document would be from the FDA. By concrete, this should include all measurable quantitative requirements. In the absence of numbers, process guidance that allows one to arrive at number criteria.

I would expect a treatise, from the FDA, regarding sample sizes and process to be included, along with measurable criteria to demonstrate safety and efficacy.

  • 1
    Why not start your research with the FDA's web site?
    – Armand
    Commented Aug 22, 2021 at 19:07
  • @BryanKrause. Thank you for the link. No, the link only discusses one aspect of the requirements (efficacy). I would like to know the name and review the authoritative document that defines the criteria for approval.
    – gatorback
    Commented Aug 22, 2021 at 19:30
  • Just an FYI- Somehow I didn't notice the answer to this question when I voted (along with the author of the answer) to close this as a duplicate. Since the answer here is different from the other answer, I'm undoing the closure.
    – Carey Gregory
    Commented Aug 23, 2021 at 2:49
  • @CareyGregory I am puzzled why action is taken based on the answer and not the fundamental nature of the question (that is different from a distantly related question).
    – gatorback
    Commented Aug 24, 2021 at 12:01
  • I disagree that it's "distantly related." It's essentially a duplicate, but the answer is different and has upvotes so worth retaining.
    – Carey Gregory
    Commented Aug 24, 2021 at 16:21

1 Answer 1


There is no "authoritative document" like you ask for. The FDA doesn't set concrete standards for efficacy and safety; rather, they review applications for vaccines and other drugs on a case-by-case basis according to safety, efficacy, other available treatments, and severity of the condition.

The FDA has issued guidance to industry about how they expect to review vaccines and consider data (they issue these sorts of guidance documents for all sorts of things), but none of it is binding. Most of it is pretty vague, for example on efficacy:

To generate sufficient data to meet the BLA approval standard, late phase clinical trials to demonstrate vaccine efficacy with formal hypothesis testing will likely need to enroll many thousands of participants, including many with medical comorbidities for trials seeking to assess protection against severe COVID-19

And for safety:

The pre-licensure safety database for preventive vaccines for infectious diseases typically consists of at least 3,000 study participants vaccinated with the dosing regimen intended for licensure. FDA anticipates that adequately powered efficacy trials for COVID-19 vaccines will be of sufficient size to provide an acceptable safety database for each of younger adult and elderly populations, provided that no significant safety concerns arise during clinical development that would warrant further pre-licensure evaluation.

This isn't saying anything about requirements, it's saying "hey, here's what people usually do to convince us, so you know what the rough expectations are".

Other guidance seems to be more specific:

To ensure that a widely deployed COVID-19 vaccine is effective, the primary efficacy endpoint point estimate for a placebo-controlled efficacy trial should be at least 50%, and the statistical success criterion should be that the lower bound of the appropriately alpha-adjusted confidence interval around the primary efficacy endpoint point estimate is >30%.

The same statistical success criterion should be used for any interim analysis designed for early detection of efficacy.

A lower bound ≤30% but >0% may be acceptable as a statistical success criterion for a secondary efficacy endpoint, provided that secondary endpoint hypothesis testing is dependent on success on the primary endpoint.

but note this is about trial design, not bounds for acceptance.

  • If this claim is true, then there is a serious problem at the FDA. It is inconceivable that they do not have a written procedure that they follow to approve vaccines.
    – gatorback
    Commented Aug 24, 2021 at 12:04
  • 3
    @gatorback Why should the FDA predict and set standards for everything ahead of time? How are they supposed to conceive of every possible drug? There are infinite possibilities, so they do it on a case by case basis when they receive an application.
    – Bryan Krause
    Commented Aug 24, 2021 at 13:05
  • @gatorback: from what I know, EMA (the EU equiv.) does pass requirements to applicants (like what to submit) but this is a 1:1 process, meaning they could in theory ask two different companies for different stuff, even on similar medicine. Generally, they don't, i.e. they start with a fairly "standard" list, but if they e.g. suspect some side-effect, they ask for more specific results. A completely cookbook submission procedure would prevent something like this, while if the cookbook were made to cover everything imaginable, the costs for the applicants would grow drastically. Commented Sep 1, 2021 at 23:32

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